Topical formulations and methods for treating hemorrhoidal pain and sphincter and smooth muscle spasm in the gastrointestinal tract

Abstract

A topical treatment for hemorrhoidal pain and for spasms of the sphincters and muscles located in the gastrointestinal (GI) tract is disclosed. The topical preparation includes the amino acid L-arginine in a pharmaceutically acceptable carrier substance, e.g., K-Y jelly, suppository, or ingestible formulation, and can be applied directly to the affected area. The topical preparation of the invention is effective for relieving the pain of hemorrhoids or for treating conditions resulting from spasms of sphincters of the GI tract including anal fissure, post operative rectal pain, hypertrophic pyloric stenosis, and pancreatitis, as well as conditions resulting from general spasm of the muscles of the GI tract.

What is claimed is: 
     
       1. A method of treating hemorrhoidal pain or other medical condition arising from a spasm in the smooth muscle of the gastrointestinal tract of a patient, said method comprising: applying a topical preparation of L-arginine in an pharmaceutically acceptable carrier to an area of the gastrointestinal tract of said patient exhibiting said hemorrhoidal pain or other medical condition in an amount effective to treat said condition.   
     
     
       2. The method of claim 1, wherein said medical condition arises from a spasm in a sphincter of the gastrointestinal tract of said patient, said sphincter of the gastrointestinal tract being selected from the group consisting of internal anal sphincter, lower esophageal sphincter, pyloric sphincter, sphincter of Oddi, and ileocolic sphincter. 
     
     
       3. The method of claim 1, wherein said patient is exhibiting a medical condition selected from the group consisting of hemorrhoidal pain, post-operative rectal pain, anal fissure, anal rectal abcess, rectal sphincter spasm, thrombosed hemorrhoids, Zenkers diverticulum, achalasia, esophageal spasm, hypertrophic pyloric stenosis, pancreatitis, irritable bowel disease, and Hirshprungs disease. 
     
     
       4. The method of claim 1, wherein said pharmaceutically acceptable carrier is water soluble jelly. 
     
     
       5. The method of claim 1, wherein said pharmaceutically acceptable carrier is an anal suppository. 
     
     
       6. The method of claim 1, wherein said pharmaceutically acceptable carrier is an electrolyte solution. 
     
     
       7. The method of claim 1, wherein said pharmaceutically acceptable carrier is a dissolvable sucker. 
     
     
       8. The method of claim 1, wherein the concentration of said L-arginine in said pharmaceutically acceptable carrier is in the range of approximately 0.01 mg to 10 mg per ml. 
     
     
       9. A topical preparation for treating hemorrhoidal pain or other medical condition arising from a spasm in the smooth muscle of the gastrointestinal tract, said preparation comprising: a therapeutically effective amount of L-arginine; and   a pharmaceutically acceptable carrier, said carrier comprising a vehicle for topical administration of said L-arginine to an area of the gastrointestinal tract affected by said medical condition, said pharmaceutically acceptable carrier selected from the group consisting essentially of water soluble jelly, anal suppository, enema solution, dimethylsulfoxide, and dissolvable sucker.   
     
     
       10. The topical preparation of claim 9, wherein the concentration of L-arginine is in the range of approximately 0.01 mg to 10 mg per ml. 
     
     
       11. An article of manufacture comprising packaging material and a pharmaceutical agent contained within said packaging material, wherein said pharmaceutical agent is therapeutically effective for treating hemorrhoidal pain or other medical condition arising from a spasm in the smooth muscle of the gastrointestinal tract of a patient, and wherein the packaging material comprises a label which indicates that the pharmaceutical agent can be used for treating hemorrhoidal pain or other medical condition arising from a spasm in the smooth muscle of the gastrointestinal tract of said patient, and wherein said pharmaceutical agent comprises L-arginine in a pharmaceutically acceptable carrier suitable for topical application. 
     
     
       12. A method of treating rectal sphincter spasm, comprising: applying a topical preparation of L-arginine in a pharmaceutically acceptable carrier to the rectal sphincter of a patient suffering rectal sphincter spasm in an amount effective to reduce said spasm.   
     
     
       13. The method of claim 12, wherein said pharmaceutically acceptable carrier is water soluble jelly. 
     
     
       14. The method of claim 12, wherein said pharmaceutically acceptable carrier is a enema solution. 
     
     
       15. The method of claim 12, wherein said pharmaceutically acceptable carrier is an anal suppository. 
     
     
       16. The method of claim 12, wherein the concentration of said L-arginine in said pharmaceutically acceptable carrier is in the range of approximately 0.001 mg to 10 mg per ml. 
     
     
       17. A method of treating pain in the anorectal area, comprising: providing a patient suffering pain in the anorectal area;   applying a topical preparation of L-arginine in a pharmaceutically acceptable carrier to the site of said pain in said anorectal area of said patient in an amount effective to reduce said pain.   
     
     
       18. The method of claim 17, wherein said pharmaceutically acceptable carrier is water soluble jelly. 
     
     
       19. The method of claim 17, wherein said pharmaceutically acceptable carrier is an anal suppository. 
     
     
       20. The method of claim 17, wherein the concentration of said L-arginine in said pharmaceutically acceptable carrier is in the range of approximately 0.001 mg to 10 mg per ml. 
     
     
       21. The method of claim 17, wherein said pain in the anorectal area is hemorrhoidal pain. 
     
     
       22. The method of claim 17, wherein said pain in the anorectal area is post-operative rectal pain. 
     
     
       23. The article of manufacture of claim 11, wherein said medical condition arises from a spasm in a sphincter of the gastrointestinal tract of said patient, said sphincter of the gastrointestinal tract being selected from the group consisting of internal anal sphincter, lower esophageal sphincter, pyloric sphincter, sphincter of Oddi, and ileocolic sphincter. 
     
     
       24. The article of manufacture of claim 11, wherein said medical condition is selected from the group consisting of hemorrhoidal pain, post-operative rectal pain, anal fissure, anal rectal abcess, rectal sphincter spasm, thrombosed hemorrhoids, Zenkers diverticulum, achalasia, esophageal spasm, hypertrophic pyloric stenosis, pancreatitis, irritable bowel disease, and Hirshprungs disease. 
     
     
       25. The article of manufacture of claim 11, wherein said pharmaceutically acceptable carrier is water soluble jelly. 
     
     
       26. The article of manufacture of claim 11, wherein said pharmaceutically acceptable carrier is an anal suppository. 
     
     
       27. The article of manufacture of claim 11, wherein said pharmaceutically acceptable carrier is an electrolyte solution. 
     
     
       28. The article of manufacture of claim 11, wherein said pharmaceutically acceptable carrier is a dissolvable sucker. 
     
     
       29. The article of manufacture of claim 11, wherein the concentration of said L-arginine in said pharmaceutically acceptable carrier is in the range of approximately 0.01 mg to 10 mg per ml.